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Not yet recruiting NCT07642700

GnRH Agonist Pretreatment in Persistent Chronic Endometritis Undergoing FET

— Observational Chronic Endometritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conventional estrogen-progesterone artificial cycle for endometrial preparation, GnRH agonist plus estrogen-progesterone for endometrial preparation.
Who it may be relevant to
Registry conditions: Chronic Endometritis. Basic parameters: 20 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Association of GnRH Agonist Pretreatment With Pregnancy Outcomes in Women With Persistent Chronic Endometritis Undergoing Frozen Embryo Transfer

Overview

Women with PCE represent a treatment-resistant phenotype in whom the endometrial inflammatory and immune status remains abnormal despite antibiotic therapy. GnRH agonist pretreatment may be most beneficial in endometrial phenotypes marked by persistent or residual inflammatory impairment rather than in all frozen embryo transfer populations.We therefore conducted a single-center prospective cohort study to investigate whether GnRH-HRT, compared with non-GnRH-based preparations, improve clinical pregnancy and live birth in women with PCE undergoing FET,

Interventions

  • Drug Conventional estrogen-progesterone artificial cycle for endometrial preparation
    No GnRH-a down-regulation. Oral estrogen is initiated directly on early menstrual cycle, followed by progesterone transformation to prepare endometrium for FET in patients with persistent chronic endometritis.
  • Drug GnRH agonist plus estrogen-progesterone for endometrial preparation
    Long-acting GnRH agonist is administered on day 2-3 of menstruation for pituitary down-regulation. After satisfactory hormonal suppression, sequential oral estrogen and progesterone are used to prepare endometrium before frozen embryo transfer in patients with persistent chronic endometritis.

Primary outcome measures

  • Clinical pregnancy rate [Time frame: 6-7 weeks]
Secondary outcome measures (2)
  • miscarriage rate [Time frame: 24 weeks]
  • Live birth rate [Time frame: 37 weeks]

Eligibility criteria

Inclusion criteria

  • Aged 20-40 years; confirmed persistent chronic endometritis (PCE) via hysteroscopy plus CD138 immunohistochemistry, defined as positive endometrial pathology after two-course antibiotic treatment for CE.
  • Frozen-thawed embryo transfer (FET) with available transferable cleavage-stage or blastocyst embryos from IVF/ICSI cycles.
  • No acute pelvic infection at enrollment; ≥1 month elapsed after completion of last antibiotic therapy for endometritis.
  • Normal uterine cavity except for inflammatory changes of PCE; no severe uterine malformation or severe intrauterine adhesion requiring surgical intervention.
  • Voluntarily sign informed consent and complete full follow-up of pregnancy outcomes

Exclusion criteria

  • History of pelvic tuberculosis, intrauterine adhesions, submucous uterine myoma or endometrial polyp before FET
  • Uncontrolled systemic endocrine disorders, autoimmune diseases (APS, SLE), severe hepatic/renal/cardiopulmonary dysfunction.
  • Known allergy to GnRH agonist for down-regulation regimen; prior long-acting GnRH-a intolerance.
  • Recent use of immunosuppressant, long-term glucocorticoid or drugs interfering endometrial development within 3 months before enrollment.
  • Lost to follow-up or plan to abandon embryo transfer after enrollment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07642700 · PCE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗